Extended Wear Ambulatory Electrocardiography And Physiological Sensor Monitor

ABSTRACT

An extended wear electrocardiography patch is provided. A flexible backing includes an elongated strip of stretchable material. An electrocardiographic electrode is respectively affixed to and conductively exposed on each end of the elongated strip. A flexible circuit is affixed on each end to the elongated strip and includes a pair of circuit traces each originating within one of the ends of the elongated strip and coupled to one of the electrocardiographic electrodes. A non-conductive receptacle securely adhered on the one end of the elongated strip and includes electrode terminals aligned to interface the pair of circuit traces to an electrocardiography monitor to obtain electrocardiographic signals through the electrocardiographic electrodes. A crypto circuit includes memory programed with a sampling rate for at least one physiological sensor provided at least one of with the electrocardiography monitor and on the flexible backing to instruct the physiological sensor to obtain readings of physiological data.

CROSS-REFERENCE TO RELATED APPLICATION

This non-provisional patent application is a continuation-in-part ofU.S. patent application Ser. No. 15/602,007, filed May 22, 2017,pending, which is a continuation of U.S. Pat. No. 9,655,538, issued May23, 2017, which is a continuation-in-part of U.S. Pat. No. 9,545,204,issued Jan. 17, 2017 and is a continuation-in-part of U.S. Pat. No.9,730,593, issued Aug. 15, 2017, and further claims priority under 35U.S.C. § 119(e) to U.S. Provisional Patent application, Ser. No.61/882,403, filed Sep. 25, 2013, the disclosures of which areincorporated by reference. This non-provisional patent application isalso a continuation-in-part of U.S. patent application Ser. No.15/605,842, filed on May 25, 2017, pending, which is acontinuation-in-part of U.S. Pat. No. 9,820,665, issued Nov. 21, 2017,which is a continuation of U.S. Pat. No. 9,433,367, issued Sep. 6, 2016,which is a continuation-in-part of U.S. Pat. No. 9,545,204, issued Jan.17, 2017 and is a continuation-in-part of U.S. Pat. No. 9,730,593,issued Aug. 15, 2017, and further claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent application Ser. No. 61/882,403, filedSep. 25, 2013, the disclosures of which are incorporated by reference.

FIELD

This application relates in general to electrocardiographic monitoringand, in particular, to an extended wear ambulatory electrocardiographyand physiological sensor monitor.

BACKGROUND

The heart emits electrical signals as a by-product of the propagation ofthe action potentials that trigger depolarization of heart fibers. Anelectrocardiogram (ECG) measures and records such electrical potentialsto visually depict the electrical activity of the heart over time.Conventionally, a standardized set format 12-lead configuration is usedby an ECG machine to record cardiac electrical signals fromwell-established traditional chest locations. Electrodes at the end ofeach lead are placed on the skin over the anterior thoracic region ofthe patient's body to the lower right and to the lower left of thesternum, on the left anterior chest, and on the limbs. Sensed cardiacelectrical activity is represented by PQRSTU waveforms that can beinterpreted post-ECG recordation to derive heart rate and physiology.The P-wave represents atrial electrical activity. The QRSTU componentsrepresent ventricular electrical activity.

An ECG is a tool used by physicians to diagnose heart problems and otherpotential health concerns. An ECG is a snapshot of heart function,typically recorded over 12 seconds, that can help diagnose rate andregularity of heartbeats, effect of drugs or cardiac devices, includingpacemakers and implantable cardioverter-defibrillators (ICDs), andwhether a patient has heart disease. ECGs are used in-clinic duringappointments, and, as a result, are limited to recording only thoseheart-related aspects present at the time of recording. Sporadicconditions that may not show up during a spot ECG recording requireother means to diagnose them. These disorders include fainting orsyncope; rhythm disorders, such as tachyarrhythmias andbradyarrhythmias; apneic episodes; and other cardiac and relateddisorders. Thus, an ECG only provides a partial picture and can beinsufficient for complete patient diagnosis of many cardiac disorders.

Diagnostic efficacy can be improved, when appropriate, through the useof long-term extended ECG monitoring. Recording sufficient ECG andrelated physiology over an extended period is challenging, and oftenessential to enabling a physician to identify events of potentialconcern. A 30-day observation period is considered the “gold standard”of ECG monitoring, yet achieving a 30-day observation day period hasproven unworkable because such ECG monitoring systems are arduous toemploy, cumbersome to the patient, and excessively costly. Ambulatorymonitoring in-clinic is implausible and impracticable. Nevertheless, ifa patient's ECG could be recorded in an ambulatory setting, therebyallowing the patient to engage in activities of daily living, thechances of acquiring meaningful information and capturing an abnormalevent while the patient is engaged in normal activities becomes morelikely to be achieved.

For instance, the long-term wear of ECG electrodes is complicated byskin irritation and the inability ECG electrodes to maintain continualskin contact after a day or two. Moreover, time, dirt, moisture, andother environmental contaminants, as well as perspiration, skin oil, anddead skin cells from the patient's body, can get between an ECGelectrode, the non-conductive adhesive used to adhere the ECG electrode,and the skin's surface. All of these factors adversely affect electrodeadhesion and the quality of cardiac signal recordings. Furthermore, thephysical movements of the patient and their clothing impart variouscompressional, tensile, and torsional forces on the contact point of anECG electrode, especially over long recording times, and an inflexiblyfastened ECG electrode will be prone to becoming dislodged.Notwithstanding the cause of electrode dislodgment, depending upon thetype of ECG monitor employed, precise re-placement of a dislodged ECGelectrode may be essential to ensuring signal capture at the samefidelity. Moreover, dislodgment may occur unbeknownst to the patient,making the ECG recordings worthless. Further, some patients may haveskin that is susceptible to itching or irritation, and the wearing ofECG electrodes can aggravate such skin conditions. Thus, a patient maywant or need to periodically remove or replace ECG electrodes during along-term ECG monitoring period, whether to replace a dislodgedelectrode, reestablish better adhesion, alleviate itching or irritation,allow for cleansing of the skin, allow for showering and exercise, orfor other purpose. Such replacement or slight alteration in electrodelocation actually facilitates the goal of recording the ECG signal forlong periods of time; however, ensuring that the level of quality of ECGrecording and patient service remains constant over an extended periodof time is dependent upon the monitoring equipment being up to a knownstandard. Use of third party consumables, such as ECG electrodes, couldundermine expectations of ECG recording fidelity and adversely skewmonitoring results.

Conventionally, Holter monitors are widely used for long-term extendedECG monitoring. Typically, they are used for only 24-48 hours. A typicalHolter monitor is a wearable and portable version of an ECG that includecables for each electrode placed on the skin and a separatebattery-powered ECG recorder. The cable and electrode combination (orleads) are placed in the anterior thoracic region in a manner similar towhat is done with an in-clinic standard ECG machine. The duration of aHolter monitoring recording depends on the sensing and storagecapabilities of the monitor, as well as battery life. A “looping” Holtermonitor (or event) can operate for a longer period of time byoverwriting older ECG tracings, thence “recycling” storage in favor ofextended operation, yet at the risk of losing event data. Althoughcapable of extended ECG monitoring, Holter monitors are cumbersome,expensive and typically only available by medical prescription, whichlimits their usability. Further, the skill required to properly placethe electrodes on the patient's chest hinders or precludes a patientfrom replacing or removing the precordial leads and usually involvesmoving the patient from the physician office to a specialized centerwithin the hospital or clinic.

The ZIO XT Patch and ZIO Event Card devices, manufactured by iRhythmTech., Inc., San Francisco, Calif., are wearable stick-on monitoringdevices that are typically worn on the upper left pectoral region torespectively provide continuous and looping ECG recording. The locationis used to simulate surgically implanted monitors. Both of these devicesare prescription-only and for single patient use. The ZIO XT Patchdevice is limited to a 14-day monitoring period, while the electrodesonly of the ZIO Event Card device can be worn for up to 30 days. The ZIOXT Patch device combines both electronic recordation components,including battery, and physical electrodes into a unitary assembly thatadheres to the patient's skin. The ZIO XT Patch device uses adhesivesufficiently strong to support the weight of both the monitor and theelectrodes over an extended period of time and to resist disadherancefrom the patient's body, albeit at the cost of disallowing removal orrelocation during the monitoring period. Moreover, throughoutmonitoring, the battery is continually depleted and battery capacity canpotentially limit overall monitoring duration. The ZIO Event Card deviceis a form of downsized Holter monitor with a recorder component thatmust be removed temporarily during baths or other activities that coulddamage the non-waterproof electronics. Both devices representcompromises between length of wear and quality of ECG monitoring,especially with respect to ease of long term use, female-friendly fit,and quality of atrial (P-wave) signals. Moreover, both devices rely onthe same set of ECG electrodes for the duration of the monitoringperiod; signal capture can suffer as the ECG electrodes disadhere fromthe patient's body over time.

Therefore, a need remains for an extended wear continuously recordingECG monitor practicably capable of being worn for a long period of timein both men and women and capable of recording atrial signals reliablywith quality assurance implemented as part of disposable componentreplenishment.

A further need remains for a device capable of recording signals idealfor arrhythmia discrimination, especially a device designed for atrialactivity recording.

SUMMARY

Physiological monitoring can be provided through a wearable monitor thatincludes two components, a flexible extended wear electrode patch and aremovable reusable monitor recorder. The wearable monitor sits centrally(in the midline) on the patient's chest along the sternum orientedtop-to-bottom. The placement of the wearable monitor in a location atthe sternal midline (or immediately to either side of the sternum), withits unique narrow “hourglass”-like shape, benefits long-term extendedwear by removing the requirement that ECG electrodes be continuallyplaced in the same spots on the skin throughout the monitoring period.Instead, the patient is free to place an electrode patch anywhere withinthe general region of the sternum, the area most likely to record highquality atrial signals or P-waves. In addition, ensuring that the levelof quality of ECG recording and patient service remains constant over anextended period of time is provided through self-authentication ofelectrode patches (and other accessories). The monitor recorderimplements a challenge response scheme upon being connected to anelectrode patch (or other accessory). Failing self-authentication, themonitor recorder signals an error condition. In addition, electrodepatches (and other accessories) can be limited to operating for only acertain period of time, or with pre-defined operational parameters orprivileges. In a further embodiment, a patient can purchase additionaltime, pre-defined operational parameters or privileges through aserver-based subscription service.

One embodiment provides an extended wear electrocardiography andphysiological sensor monitor recorder. A sealed housing is adapted to beremovably secured into the non-conductive receptacle on a disposableextended wear electrode patch. Electronic circuitry is included withinthe sealed housing. An externally-powered micro-controller is operableto execute under micro programmable control only upon authentication ofthe disposable extended wear electrode patch during power up of theelectronic circuitry. An electrocardiographic front end circuit iselectrically interfaced to the micro-controller and is operable to senseelectrocardiographic signals through electrocardiographic electrodesprovided on the disposable extended wear electrode patch.Externally-powered flash memory is electrically interfaced with themicro-controller and is operable to store samples of theelectrocardiographic signals.

A further embodiment provides an extended wear electrocardiographypatch. A flexible backing includes an elongated strip of stretchablematerial. An electrocardiographic electrode is respectively affixed toand conductively exposed on each end of the elongated strip. A flexiblecircuit is affixed on each end to the elongated strip and includes apair of circuit traces each originating within one of the ends of theelongated strip and coupled to one of the electrocardiographicelectrodes. A non-conductive receptacle securely adhered on the one endof the elongated strip and includes electrode terminals aligned tointerface the pair of circuit traces to an electrocardiography monitorto obtain electrocardiographic signals through the electrocardiographicelectrodes. A crypto circuit includes memory programed with a samplingrate for at least one physiological sensor provided at least one of withthe electrocardiography monitor and on the flexible backing to instructthe physiological sensor to obtain readings of physiological data.

A still further embodiment provides an extended wear electrocardiographyand physiological sensor monitor. An electrocardiography monitorincludes a sealed housing and electronic circuitry within the sealedhousing, including an externally-powered micro-controller and anelectrocardiographic front end circuit electrically interfaced to themicro-controller and operable to sense electrocardiographic signals. Anelectrocardiography patch includes a flexible backing formed of anelongated strip of stretchable material and an electrocardiographicelectrode affixed to and conductively exposed on a contact surface ofeach end of the elongated strip. A flexible circuit is affixed on eachend to the elongated strip and includes a pair of circuit traces eachoriginating within one of the ends of the elongated strip andelectrically coupled to one of the electrocardiographic electrodes. Anon-conductive receptacle is securely adhered on the one end of theelongated strip opposite the contact surface and formed to removablyreceive the electrocardiography monitor. The non-conductive receptacleincludes electrode terminals aligned to electrically interface the pairof circuit traces to the electrocardiography monitor. A crypto circuitincludes memory programed with a sampling rate for at least onephysiological sensor provided at least one of with theelectrocardiography monitor and on the flexible backing to instruct thephysiological sensor to obtain readings of physiological data.

The monitoring patch is especially suited to the female anatomy. Thenarrow longitudinal midsection can fit nicely within the intermammarycleft of the breasts without inducing discomfort, whereas conventionalpatch electrodes are wide and, if adhesed between the breasts, wouldcause chafing, irritation, frustration, and annoyance, leading to lowpatient compliance.

The foregoing aspects enhance ECG monitoring performance and quality,facilitating long-term ECG recording, critical to accurate arrhythmiadiagnosis.

In addition, the foregoing aspects enhance comfort in women (and certainmen), but not irritation of the breasts, by placing the monitoring patchin the best location possible for optimizing the recording of cardiacsignals from the atrium, another feature critical to proper arrhythmiadiagnosis.

Finally, the foregoing aspects as relevant to monitoring are equallyapplicable to recording other physiological measures, such astemperature, respiratory rate, blood sugar, oxygen saturation, and bloodpressure, as well as other measures of body chemistry and physiology.

Still other embodiments will become readily apparent to those skilled inthe art from the following detailed description, wherein are describedembodiments by way of illustrating the best mode contemplated. As willbe realized, other and different embodiments are possible and theembodiments' several details are capable of modifications in variousobvious respects, all without departing from their spirit and the scope.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not as restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 are diagrams showing, by way of examples, an extended wearelectrocardiography and physiological sensor monitor respectively fittedto the sternal region of a female patient and a male patient.

FIG. 3 is a functional block diagram showing a system for providing aself-authenticating electrocardiography monitoring circuit in accordancewith one embodiment.

FIG. 4 is a perspective view showing an extended wear electrode patchwith a monitor recorder in accordance with one embodiment inserted.

FIG. 5 is a perspective view showing the monitor recorder of FIG. 4.

FIG. 6 is a perspective view showing the extended wear electrode patchof FIG. 4 without a monitor recorder inserted.

FIG. 7 is a bottom plan view of the monitor recorder of FIG. 4.

FIG. 8 is a top view showing the flexible circuit of the extended wearelectrode patch of FIG. 4 when mounted above the flexible backing.

FIG. 9 is an exploded view showing the component layers of the extendedwear electrode patch of FIG. 4.

FIG. 10 is an alternative exploded view showing the component layers ofthe extended wear electrode patch of FIG. 4.

FIG. 11 is an exploded view showing an integrated flex circuit of theextended wear electrode patch of FIG. 10.

FIG. 12 is a functional block diagram showing the component architectureof the circuitry of the monitor recorder of FIG. 4.

FIG. 13 is a functional block diagram showing the circuitry of theextended wear electrode patch of FIG. 4.

FIG. 14 is a flow diagram showing a monitor recorder-implemented methodfor monitoring ECG data for use in the monitor recorder of FIG. 4.

FIG. 15 is a graph showing, by way of example, a typical ECG waveform.

FIG. 16 is a flow diagram showing a method for offloading and convertingECG and other physiological data from an extended wearelectrocardiography and physiological sensor monitor in accordance withone embodiment.

FIG. 17 is a flow diagram showing a method for providing aself-authenticating electrocardiography monitoring circuit in accordancewith one embodiment.

FIG. 18 is a flow diagram showing, by way of example, a process forobtaining physiological data from a physiological sensor.

DETAILED DESCRIPTION

Physiological monitoring can be provided through a wearable monitor thatincludes two components, a flexible extended wear electrode patch and aremovable reusable monitor recorder. FIGS. 1 and 2 are diagrams showing,by way of examples, an extended wear electrocardiography andphysiological sensor monitor 12, including a monitor recorder 14 inaccordance with one embodiment, respectively fitted to the sternalregion of a female patient 10 and a male patient 11. The wearablemonitor 12 sits centrally (in the midline) on the patient's chest alongthe sternum 13 oriented top-to-bottom with the monitor recorder 14preferably situated towards the patient's head. In a further embodiment,the orientation of the wearable monitor 12 can be correctedpost-monitoring, as further described infra. The electrode patch 15 isshaped to fit comfortably and conformal to the contours of the patient'schest approximately centered on the sternal midline 16 (or immediatelyto either side of the sternum 13). The distal end of the electrode patch15 extends towards the Xiphoid process and, depending upon the patient'sbuild, may straddle the region over the Xiphoid process. The proximalend of the electrode patch 15, located under the monitor recorder 14, isbelow the manubrium and, depending upon patient's build, may straddlethe region over the manubrium.

The placement of the wearable monitor 12 in a location at the sternalmidline 16 (or immediately to either side of the sternum 13)significantly improves the ability of the wearable monitor 12 tocutaneously sense cardiac electric signals, particularly the P-wave (oratrial activity) and, to a lesser extent, the QRS interval signals inthe ECG waveforms that indicate ventricular activity, whilesimultaneously facilitating comfortable long-term wear for many weeks.The sternum 13 overlies the right atrium of the heart and the placementof the wearable monitor 12 in the region of the sternal midline 13 putsthe ECG electrodes of the electrode patch 15 in a location betteradapted to sensing and recording P-wave signals than other placementlocations, say, the upper left pectoral region or lateral thoracicregion or the limb leads. In addition, placing the lower or inferiorpole (ECG electrode) of the electrode patch 15 over (or near) theXiphoid process facilitates sensing of ventricular activity and providessuperior recordation of the QRS interval.

The monitor recorder 14 of the extended wear electrocardiography andphysiological sensor monitor 12 senses and records the patient's ECGdata into an onboard memory. Over time, disposable electrode patches 15will require replacement and ensuring that the level of quality of ECGrecording and patient service remains constant over an extended periodof time is dependent upon the monitoring equipment, particularly thereplacement electrode patches 15, being up to a known standard. FIG. 3is a functional block diagram showing a system 120 for providing aself-authenticating electrocardiography monitoring circuit in accordancewith one embodiment. Self-authentication allows quality and safetyexpectations to be maintained. The monitor recorder 14 is a reusablecomponent that can be fitted during patient monitoring into anon-conductive receptacle provided on the electrode patch 15, as furtherdescribed infra with reference to FIG. 4, and later removed foroffloading of stored ECG data or to receive revised programming. Themonitor recorder 14 executes an authentication protocol as part of apower up sequence, as further described infra with reference to FIG. 11.Following completion of ECG monitoring, the monitor recorder 14 can beconnected to a download station 125, which could be a programmer orother device that permits the retrieval of stored ECG monitoring data,execution of diagnostics on or programming of the monitor recorder 14,or performance of other functions. The monitor recorder 14 has a set ofelectrical contacts (not shown) that enable the monitor recorder 14 tophysically interface to a set of terminals 128 on a paired receptacle127 of the download station 125. In turn, the download station 125executes a communications or offload program 126 (“Offload”) or similarprogram that interacts with the monitor recorder 14 via the physicalinterface to retrieve the stored ECG monitoring data. The downloadstation 125 could be a server, personal computer, tablet or handheldcomputer, smart mobile device, or purpose-built programmer designedspecific to the task of interfacing with a monitor recorder 14. Stillother forms of download station 125 are possible.

Upon retrieving stored ECG monitoring data from a monitor recorder 14,middleware first operates on the retrieved data to adjust the ECGwaveform, as necessary, and to convert the retrieved data into a formatsuitable for use by third party post-monitoring analysis software. Theformatted data can then be retrieved from the download station 125 overa hard link 135 using a control program 137 (“Ctl”) or analogousapplication executing on a personal computer 136 or other connectablecomputing device, via a communications link (not shown), whether wiredor wireless, or by physical transfer of storage media (not shown). Thepersonal computer 136 or other connectable device may also executemiddleware that converts ECG data and other information into a formatsuitable for use by a third-party post-monitoring analysis program, asfurther described infra with reference to FIG. 13. Note that formatteddata stored on the personal computer 136 would have to be maintained andsafeguarded in the same manner as electronic medical records (EMRs) 134in the secure database 124, as further discussed infra. In a furtherembodiment, the download station 125 is able to directly interface withother devices over a computer communications network 121, which could besome combination of a local area network and a wide area network,including the Internet, over a wired or wireless connection.

A client-server model could be used to employ a server 122 to remotelyinterface with the download station 125 over the network 121 andretrieve the formatted data or other information. The server 122executes a patient management program 123 (“Mgt”) or similar applicationthat stores the retrieved formatted data and other information in asecure database 124 cataloged in that patient's EMRs 134. In addition,the patient management program 123 could manage a subscription servicethat authorizes a monitor recorder 14 to operate for a set period oftime or under pre-defined operational parameters and privileges, such asdescribed in infra with reference to FIG. 13.

The patient management program 123, or other trusted application, alsomaintains and safeguards the secure database 124 to limit access topatient EMRs 134 to only authorized parties for appropriate medical orother uses, such as mandated by state or federal law, such as under theHealth Insurance Portability and Accountability Act (HIPAA) or per theEuropean Union's Data Protection Directive. For example, a physician mayseek to review and evaluate his patient's ECG monitoring data, assecurely stored in the secure database 124. The physician would executean application program 130 (“Pgm”), such as a post-monitoring ECGanalysis program, on a personal computer 129 or other connectablecomputing device, and, through the application 130, coordinate access tohis patient's EMRs 134 with the patient management program 123. Otherschemes and safeguards to protect and maintain the integrity of patientEMRs 134 are possible.

During use, the electrode patch 15 is first adhesed to the skin alongthe sternal midline 16 (or immediately to either side of the sternum13). A monitor recorder 14 is then snapped into place on the electrodepatch 15 to initiate ECG monitoring. FIG. 4 is a perspective viewshowing an extended wear electrode patch 15 with a monitor recorder 14in accordance with one embodiment inserted. The body of the electrodepatch 15 is preferably constructed using a flexible backing 20 formed asan elongated strip 21 of wrap knit or similar stretchable material witha narrow longitudinal mid-section 23 evenly tapering inward from bothsides. A pair of cut-outs 22 between the distal and proximal ends of theelectrode patch 15 create a narrow longitudinal midsection 23 or“isthmus” and defines an elongated “hourglass”-like shape, when viewedfrom above.

The electrode patch 15 incorporates features that significantly improvewearability, performance, and patient comfort throughout an extendedmonitoring period. During wear, the electrode patch 15 is susceptible topushing, pulling, and torqueing movements, including compressional andtorsional forces when the patient bends forward, and tensile andtorsional forces when the patient leans backwards. To counter thesestress forces, the electrode patch 15 incorporates strain and crimpreliefs, such as described in commonly-assigned U.S. Pat. No. 9,545,204,issued Jan. 17, 2017, the disclosure of which is incorporated byreference. In addition, the cut-outs 22 and longitudinal midsection 23help minimize interference with and discomfort to breast tissue,particularly in women (and gynecomastic men). The cut-outs 22 andlongitudinal midsection 23 further allow better conformity of theelectrode patch 15 to sternal bowing and to the narrow isthmus of flatskin that can occur along the bottom of the intermammary cleft betweenthe breasts, especially in buxom women. The cut-outs 22 and longitudinalmidsection 23 help the electrode patch 15 fit nicely between a pair offemale breasts in the intermammary cleft. Still other shapes, cut-outsand conformities to the electrode patch 15 are possible.

The monitor recorder 14 removably and reusably snaps into anelectrically non-conductive receptacle 25 during use. The monitorrecorder 14 contains electronic circuitry for recording and storing thepatient's electrocardiography as sensed via a pair of ECG electrodesprovided on the electrode patch 15, such as described incommonly-assigned U.S. Pat. No. 9,720,593, issued Aug. 15, 2017, thedisclosure of which is incorporated by reference. The non-conductivereceptacle 25 is provided on the top surface of the flexible backing 20with a retention catch 26 and tension clip 27 molded into thenon-conductive receptacle 25 to conformably receive and securely holdthe monitor recorder 14 in place.

The monitor recorder 14 includes a sealed housing that snaps into placein the non-conductive receptacle 25. FIG. 5 is a perspective viewshowing the monitor recorder 14 of FIG. 4. The sealed housing 50 of themonitor recorder 14 intentionally has a rounded isoscelestrapezoidal-like shape 52, when viewed from above, such as described incommonly-assigned U.S. Design Pat. No. D717955, issued Nov. 18, 2014,the disclosure of which is incorporated by reference. The edges 51 alongthe top and bottom surfaces are rounded for patient comfort. The sealedhousing 50 is approximately 47 mm long, 23 mm wide at the widest point,and 7 mm high, excluding a patient-operable tactile-feedback button 55.The sealed housing 50 can be molded out of polycarbonate, ABS, or analloy of those two materials. The button 55 is waterproof and thebutton's top outer surface is molded silicon rubber or similar softpliable material. A retention detent 53 and tension detent 54 are moldedalong the edges of the top surface of the housing 50 to respectivelyengage the retention catch 26 and the tension clip 27 molded intonon-conductive receptacle 25. Other shapes, features, and conformitiesof the sealed housing 50 are possible.

The electrode patch 15 is intended to be disposable. The monitorrecorder 14, however, is reusable and can be transferred to successiveelectrode patches 15 to ensure continuity of monitoring. The placementof the wearable monitor 12 in a location at the sternal midline 16 (orimmediately to either side of the sternum 13) benefits long-termextended wear by removing the requirement that ECG electrodes becontinually placed in the same spots on the skin throughout themonitoring period. Instead, the patient is free to place an electrodepatch 15 anywhere within the general region of the sternum 13.

As a result, at any point during ECG monitoring, the patient's skin isable to recover from the wearing of an electrode patch 15, whichincreases patient comfort and satisfaction, while the monitor recorder14 ensures ECG monitoring continuity with minimal effort. A monitorrecorder 14 is merely unsnapped from a worn out electrode patch 15, theworn out electrode patch 15 is removed from the skin, a new electrodepatch 15 is adhered to the skin, possibly in a new spot immediatelyadjacent to the earlier location, and the same monitor recorder 14 issnapped into the new electrode patch 15 to reinitiate and continue theECG monitoring.

During use, the electrode patch 15 is first adhered to the skin in thesternal region. FIG. 6 is a perspective view showing the extended wearelectrode patch 15 of FIG. 4 without a monitor recorder 14 inserted. Aflexible circuit 32 is adhered to each end of the flexible backing 20. Adistal circuit trace 33 and a proximal circuit trace (not shown)electrically couple ECG electrodes (not shown) to a pair of electricalpads 34. The electrical pads 34 are provided within a moisture-resistantseal 35 formed on the bottom surface of the non-conductive receptacle25. When the monitor recorder 14 is securely received into thenon-conductive receptacle 25, that is, snapped into place, theelectrical pads 34 interface to electrical contacts (not shown)protruding from the bottom surface of the monitor recorder 14, and themoisture-resistant seal 35 enables the monitor recorder 14 to be worn atall times, even during bathing or other activities that could expose themonitor recorder 14 to moisture.

In addition, a battery compartment 36 is formed on the bottom surface ofthe non-conductive receptacle 25, and a pair of battery leads (notshown) electrically interface the battery to another pair of theelectrical pads 34. The battery contained within the battery compartment35 can be replaceable, rechargeable or disposable.

The monitor recorder 14 draws power externally from the battery providedin the non-conductive receptacle 25, thereby uniquely obviating the needfor the monitor recorder 14 to carry a dedicated power source. FIG. 7 isa bottom plan view of the monitor recorder 14 of FIG. 4. A cavity 58 isformed on the bottom surface of the sealed housing 50 to accommodate theupward projection of the battery compartment 36 from the bottom surfaceof the non-conductive receptacle 25, when the monitor recorder 14 issecured in place on the non-conductive receptacle 25. A set ofelectrical contacts 56 protrude from the bottom surface of the sealedhousing 50 and are arranged in alignment with the electrical pads 34provided on the bottom surface of the non-conductive receptacle 25 toestablish electrical connections between the electrode patch 15 and themonitor recorder 14. In addition, a seal coupling 57 circumferentiallysurrounds the set of electrical contacts 56 and securely mates with themoisture-resistant seal 35 formed on the bottom surface of thenon-conductive receptacle 25.

The placement of the flexible backing 20 on the sternal midline 16 (orimmediately to either side of the sternum 13) also helps to minimize theside-to-side movement of the wearable monitor 12 in the left- andright-handed directions during wear. To counter the dislodgment of theflexible backing 20 due to compressional and torsional forces, a layerof non-irritating adhesive, such as hydrocolloid, is provided at leastpartially on the underside, or contact, surface of the flexible backing20, but only on the distal end 30 and the proximal end 31. As a result,the underside, or contact surface of the longitudinal midsection 23 doesnot have an adhesive layer and remains free to move relative to theskin. Thus, the longitudinal midsection 23 forms a crimp relief thatrespectively facilitates compression and twisting of the flexiblebacking 20 in response to compressional and torsional forces. Otherforms of flexible backing crimp reliefs are possible.

Unlike the flexible backing 20, the flexible circuit 32 is only able tobend and cannot stretch in a planar direction. The flexible circuit 32can be provided either above or below the flexible backing 20. FIG. 8 isa top view showing the flexible circuit 32 of the extended wearelectrode patch 15 of FIG. 4 when mounted above the flexible backing 20.A distal ECG electrode 38 and proximal ECG electrode 39 are respectivelycoupled to the distal and proximal ends of the flexible circuit 32. Astrain relief 40 is defined in the flexible circuit 32 at a locationthat is partially underneath the battery compartment 36 when theflexible circuit 32 is affixed to the flexible backing 20. The strainrelief 40 is laterally extendable to counter dislodgment of the ECGelectrodes 38, 39 due to tensile and torsional forces. A pair of strainrelief cutouts 41 partially extend transversely from each opposite sideof the flexible circuit 32 and continue longitudinally towards eachother to define in ‘S’-shaped pattern, when viewed from above. Thestrain relief respectively facilitates longitudinal extension andtwisting of the flexible circuit 32 in response to tensile and torsionalforces. Other forms of circuit board strain relief are possible.

When provided above the flexible backing 20, adhesive layers areprovided above and below the flexible circuit 32. FIG. 9 is an explodedview showing the component layers of the electrode patch 15 of FIG. 4.The flexible backing 20 is constructed of a wearable gauze, latex, orsimilar wrap knit or stretchable and wear-safe material 54, such as aTricot-type linen with a pressure sensitive adhesive (PSA) on theunderside, or contact, surface. The wearable material 194 is coated witha layer 193, 192 of non-irritating adhesive, such as hydrocolloid, tofacilitate long-term wear. The hydrocolloid, for instance, is typicallymade of mineral oil, cellulose and water and lacks any chemicalsolvents, so should cause little itching or irritation. Moreover,hydrocolloid is thicker and more gel-like than most forms of PSA andprovides cushioning between the relatively rigid and unyieldingnon-conductive receptacle 25 and the patient's skin. In a furtherembodiment, the layer of non-irritating adhesive can be contoured, suchas by forming the adhesive with a concave or convex cross-section;surfaced, such as through stripes or crosshatches of adhesive, or byforming dimples in the adhesive's surface; or applied discontinuously,such as with a formation of discrete dots of adhesive.

As described supra with reference to FIG. 8, a flexible circuit can beadhered to either the outward facing surface or the underside, orcontact, surface of the flexible backing 20. For convenience, a flexiblecircuit 197 is shown, such as in FIG. 9, relative to the outward facingsurface of the wearable material 194 and is adhered respectively on adistal end by a distal electrode seal 195 and on a proximal end by aproximal electrode seal 195. In a further embodiment, the flexiblecircuit 197 can be provided on the underside, or contact, surface of thewearable material 194. Through the electrode seals, only the distal andproximal ends of the flexible circuit 197 are attached to the wearablematerial 194, which enables the strain relief 50 (shown in FIG. 8) torespectively longitudinally extend and twist in response to tensile andtorsional forces during wear. Similarly, the layer 193, 192 ofnon-irritating adhesive is provided on the underside, or contact,surface of the wearable material 194 only on the proximal and distalends, which enables the longitudinal midsection 23 (shown in FIG. 4) torespectively bow outward and away from the sternum 13 or twist inresponse to compressional and torsional forces during wear. In a furtherembodiment, the layer 193, 192 of non-irritating adhesive is providedalong a length of the wearable material 194.

A pair of openings 196 is defined on the distal and proximal ends of thewearable material 194 and layer 193, 192 of non-irritating adhesive forECG electrodes 38, 39 (shown in FIG. 8). The openings 196 serve as “gel”wells with a layer of hydrogel 191 being used to fill the bottom of eachopening 196 as a conductive material that aids electrode signal pick up.The entire underside, or contact, surface of the flexible backing 20 isprotected prior to use by a liner layer 190 that is peeled away.

The non-conductive receptacle 25 includes a main body 64 that is moldedout of polycarbonate, ABS, or an alloy of those two materials to providea high surface energy to facilitate adhesion of an adhesive seal 63. Themain body 64 is attached to a battery printed circuit board 62 by theadhesive seal 63 and, in turn, the battery printed circuit board 62 isadhesed to the flexible circuit 197 with an upper flexible circuit seal60. A pair of conductive transfer adhesive points 61 or, alternatively,metallic rivets or similar conductive and structurally unifyingcomponents, connect the circuit traces 33, 37 (shown in FIG. 8) of theflexible circuit 197 to the battery printed circuit board 62. The mainbody 64 has a retention catch 26 and tension clip 27 (shown in FIG. 4)that fixably and securely receive a monitor recorder 14 (shown in FIG.4), and includes a recess within which to circumferentially receive adie cut gasket 65, either rubber, urethane foam, or similar suitablematerial, to provide a moisture resistant seal to the set of pads 34(shown in FIG. 6).

Together, the components of the electrode patch 15, as described above,form a signal path for transmission of ECG data sensed by theelectrodes, to the recorder monitor for collection and transfer to adownload station. Reducing a number of components in the signal path cansimplify fabrication and decrease manufacturing costs, as well asenhance noise reduction. FIG. 10 is an alternative exploded view showingthe component layers of the electrode patch 15 of FIG. 4. Thenon-conductive receptacle 20 is provided on a top surface of theflexible backing 25 to conformably receive and securely hold the monitorrecorder 14 (shown in FIG. 4) in place. The flexible backing 25 caninclude an integrated flex circuit 73, electrode seal 74, patientadhesive 76, and a liner layer 77. The flexible backing can also includeECG electrodes (not shown) and hydrogel 75, which is in contact with theECG electrodes.

The integrated flex circuit 73 can be constructed from material, such aspolyester substrate and silver ink, and can include a pair of circuittraces (not shown), one on a distal end and one on a proximal end of theintegrated flex circuit. The circuit traces electrically couple the ECGelectrodes to a pair of electrical pads 84 on the integrated flexcircuit. Specifically, the silver ink is applied to the polyestersubstrate of the integrated flex circuit 73 for electrical conductivityof the circuit traces (shown in FIG. 8) using screen-printing,pad-printing, or flexography. Other types of material, ink and means forelectrical conductivity are possible. Two or more of the electrical padsare formed on the outward facing surface of the integrated flex circuit,which can also form a bottom surface of the non-conductive receptacle20. Additionally, one or more electrical pads can also be located on acontact surface of the integrated flexible circuit.

A battery 79 is adhered directly to the outward facing surface of theintegrated flex circuit 73, removing the need for a battery printedcircuit board, adhesive points and a flexible circuit seal, as shown inFIG. 9, which is described above in detail. The battery 79 can besoldered to the integrated flex circuit 73 or alternatively, the battery79 is affixed to the integrated flex circuit 73 via a clip 80. Othermeans for attaching the battery 79 to the integrated flex circuit 73 arepossible.

A layer of patient adhesive 76 is provided on the contact surface of theintegrated flex circuit 73 via one or more electrode seals 74. Theelectrode seal 74 includes a double sided layer of adhesive to connectthe integrated flex circuit 73 and the adhesive layer 76. The adhesivelayer 76 is a type of wearable material coated on a bottom, or contact,surface with a layer of non-irritating adhesive, such as hydrocolloid.The wearable material can include gauze, latex, wrap knit, or othertypes of stretchable and wear-safe material, such as a Tricot-type linenwith a pressure sensitive adhesive on the underside, or contact surface.The electrode seal 74 and adhesive layer 76 can each cover the entirecontact surface of the integrated flex circuit 73 or merely a portion,such as on proximal and distal ends of the integrated flex circuit 73.

Further, openings 78 are defined on the distal and proximal ends of eachof the electrode seal 74 and adhesive layer 76 for ECG electrodes 38, 39(shown in FIG. 8). The openings serve as “gel” wells with a layer ofhydrogel 75 used to fill the bottom of each opening as a conductivematerial that aids signal pick up by the electrodes, which areelectrically coupled to the circuit traces. The entire underside, orcontact, surface of the flexible backing 20 is protected prior to use bya liner layer 77 that is peeled away.

The non-conductive receptacle 20 includes a main body 71 that is moldedout of polycarbonate, ABS, or an alloy of those two materials to providea high surface energy to facilitate adhesion of an adhesive seal 72. Themain body 71 is adhesed to the integrated flex circuit 73 via theadhesive seal 72 and has a retention catch 26 and tension clip 27 (shownin FIG. 4) that fixably and securely receive a monitor recorder 14 (notshown). The main body 71 also includes a recess within which tocircumferentially receive a die cut gasket (not shown), either rubber,urethane foam, or similar suitable material, to provide a moistureresistant seal to the set of pads 34 (shown in FIG. 6).

Decreasing a number of components in the electrode patch can helpdecrease noise in the collection of ECG data from a patient, which isextremely important because some types of noise can look like certainkinds of arrythmias. The integrated flex circuit includes a battery,removing the need for a separate printed circuit board. FIG. 11 is anexploded view showing the integrated flex circuit 73 of the electrodepatch of FIG. 10. The integrated flex circuit 73 is formed from a singlepiece of material, such as polyester substrate. As described above withrespect to FIG. 4, a pair of cut-outs between distal and proximal endsof the electrode patch create a narrow longitudinal midsection anddefines an elongated “hourglass”-like shape of the integrated flexcircuit, in one embodiment. The integrated flex circuit 73 can also beshaped in the elongated “hourglass”-like shape, consistent with theelectrode patch. Further, an upper portion 80 of the “hourglass” shapedintegrated flex circuit is formed on proximal end and sized to hold theelectrically non-conductive receptacle (not shown). The upper 80 portionhas a longer and wider profile than the lower part 81 of the“hourglass,” which is sized primarily to allow just the placement of anECG electrode. Additionally, the integrated flex circuit 73 includes aduplicate 82 of the upper portion 80 that is a mirror image andconnected to the upper portion along one side. The mirror copy 82 of theupper portion is folded over the upper portion 80. Other shapes of theelectrode patch and the integrated flex circuit are possible, includingrectangular, square, oval, and circular.

Each of the upper portion and the mirror copy of the upper portion caninclude electrical pads 85, 86, which establish electrical connectionsbetween the electrode patch and the monitor recorder. Specifically, theelectrical pads on the mirror copy of the upper portion interface toelectrical contacts (not shown) protruding from the bottom surface ofthe monitor recorder.

In a further embodiment, one or both of the electrode patch 15 andintegrated flex circuit 73 form a different shape, such as a longrectangular strip or another shape. In such configuration, a portion ofthe integrated flex circuit 73 is designated as the upper portion andduplicated to form a mirror image, which is folded over the designedupper portion.

Due to the flexible nature of the integrated circuit, a stiffener isused to prevent unnecessary bending of the circuit, such as when apatient presses a tactile feedback button on the monitor to mark eventsor to perform other functions. In one embodiment, the stiffener can bethe same shape and size as the integrated flex circuit and can be madefrom epoxy laminate sheets or fiberglass. In another embodiment, theupper portion is folded over a stiffener, which is located between theupper portion and the mirror copy, and laminated together.

When inserted in the non-conductive receptacle of the electrode patch,the monitor recorder performs ECG monitoring and other functions througha micro controlled architecture. FIG. 12 is a functional block diagramshowing the component architecture of the circuitry 90 of the monitorrecorder 14 of FIG. 4. The circuitry 90 is externally powered through abattery provided in the non-conductive receptacle 25 (shown in FIG. 6).Both power and raw ECG signals, which originate in the pair of ECGelectrodes 38, 39 (shown in FIG. 8) on the distal and proximal ends ofthe electrode patch 15, are received through an external connector 95that mates with a corresponding physical connector on the electrodepatch 15. The external connector 95 includes the set of electricalcontacts 56 (shown in FIG. 7) that protrude from the bottom surface ofthe sealed housing 50 and which physically and electrically interfacewith the set of pads 34 (shown in FIG. 6) provided on the bottom surfaceof the non-conductive receptacle 25. The external connector 95 includeselectrical contacts 56 for data download, microcontrollercommunications, power, analog inputs, and a peripheral expansion port.The arrangement of the pins on the external connector 95 of the monitorrecorder 14 and the device into which the monitor recorder 14 isattached, whether an electrode patch 15 or download station 125 (shownin FIG. 3), follow the same electrical pin assignment convention tofacilitate interoperability. The external connector 65 also serves as aphysical interface to a download station that permits the retrieval ofstored ECG monitoring data, communication with the monitor recorder 14,and performance of other functions.

Operation of the circuitry 90 of the monitor recorder 14 is managed by amicrocontroller 91. The micro-controller 91 includes a program memoryunit containing internal flash memory that is readable and writeable.The internal flash memory can also be programmed externally. Themicro-controller 91 draws power externally from the battery provided onthe electrode patch 15 via a pair of the electrical contacts 56. Themicrocontroller 91 connects to the ECG front end circuit 93 thatmeasures raw cutaneous electrical signals and generates an analog ECGsignal representative of the electrical activity of the patient's heartover time.

The circuitry 90 of the monitor recorder 14 also includes a flash memory92, which the micro-controller 91 uses for storing ECG monitoring dataand other physiology and information. The flash memory 92 also drawspower externally from the battery provided on the electrode patch 15 viaa pair of the electrical contacts 56. Data is stored in a serial flashmemory circuit, which supports read, erase and program operations over acommunications bus. The flash memory 92 enables the microcontroller 91to store digitized ECG data. The communications bus further enables theflash memory 92 to be directly accessed externally over the externalconnector 95 when the monitor recorder 14 is interfaced to a downloadstation.

The circuitry 90 of the monitor recorder 14 further includes anactigraphy sensor 94 implemented as a 3-axis accelerometer. Theaccelerometer may be configured to generate interrupt signals to themicrocontroller 91 by independent initial wake up and free fall events,as well as by device position. In addition, the actigraphy provided bythe accelerometer can be used during post-monitoring analysis to correctthe orientation of the monitor recorder 14 if, for instance, the monitorrecorder 14 has been inadvertently installed upside down, that is, withthe monitor recorder 14 oriented on the electrode patch 15 towards thepatient's feet, as well as for other event occurrence analyses, such asdescribed in commonly-assigned U.S. Pat. No. 9,737,224, issued Aug. 22,2017, the disclosure of which is incorporated by reference.

The microcontroller 91 includes an expansion port 98 that also utilizesthe communications bus. External devices, separately drawing powerexternally from the battery provided on the electrode patch 15 or othersource, can interface to the microcontroller 91 over the expansion portin half duplex mode. For instance, an external physiology sensor can beprovided as part of the circuitry 90 of the monitor recorder 14, or canbe provided on the electrode patch 15 with communication with themicro-controller 91 provided over one of the electrical contacts 56. Thephysiology sensor can include a SpO₂ sensor, blood pressure sensor,temperature sensor, respiratory rate sensor, glucose sensor, airflowsensor, volumetric pressure sensing, or other types of sensor ortelemetric input sources. For instance, the integration of an airflowsensor is described in commonly-assigned U.S. Pat. No. 9,364,155, issuedJun. 14, 2016, the disclosure which is incorporated by reference. In afurther embodiment, a wireless interface for interfacing with otherwearable (or implantable) physiology monitors, as well as data offloadand programming, can be provided as part of the circuitry 90 of themonitor recorder 14, or can be provided on the electrode patch 15 withcommunication with the micro-controller 91 provided over one of theelectrical contacts 56, such as described in commonly-assigned U.S. Pat.No. 9,433,367, issued Sep. 6, 2016 the disclosure of which isincorporated by reference.

Finally, the circuitry 90 of the monitor recorder 14 includespatient-interfaceable components, including a tactile feedback button96, which a patient can press to mark events or to perform otherfunctions, and a buzzer 67, such as a speaker, magnetic resonator orpiezoelectric buzzer. The buzzer 97 can be used by the microcontroller91 to output feedback to a patient such as to confirm power up andinitiation of ECG monitoring. Still other components as part of thecircuitry 90 of the monitor recorder 14 are possible.

While the monitor recorder 14 operates under micro control, some of theelectrical components of the electrode patch 15 operate passively, whileothers are active. FIG. 13 is a functional block diagram showing thecircuitry 100 of the extended wear electrode patch 15 of FIG. 4. Thecircuitry 100 of the electrode patch 15 is electrically coupled with thecircuitry 90 of the monitor recorder 14 through an external connector104. The external connector 104 is terminated through the set of pads 34provided on the bottom of the non-conductive receptacle 25, whichelectrically mate to corresponding electrical contacts 56 protrudingfrom the bottom surface of the sealed housing 50 to electricallyinterface the monitor recorder 14 to the electrode patch 15.

The circuitry 100 of the electrode patch 15 performs three primaryfunctions. First, a battery 101 is provided in a battery compartmentformed on the bottom surface of the non-conductive receptacle 25. Thebattery 101 is electrically interfaced to the circuitry 90 of themonitor recorder 14 as a source of external power. The uniqueprovisioning of the battery 101 on the electrode patch 15 providesseveral advantages. First, the locating of the battery 101 physically onthe electrode patch 15 lowers the center of gravity of the overallwearable monitor 12 and thereby helps to minimize shear forces and theeffects of movements of the patient and clothing. Moreover, the housing50 of the monitor recorder 14 is sealed against moisture and providingpower externally avoids having to either periodically open the housing50 for the battery replacement, which also creates the potential formoisture intrusion and human error, or to recharge the battery, whichcan potentially take the monitor recorder 14 off line for hours at atime. In addition, the electrode patch 15 is intended to be disposable,while the monitor recorder 14 is a reusable component. Each time thatthe electrode patch 15 is replaced, a fresh battery is provided for theuse of the monitor recorder 14, which enhances ECG monitoringperformance quality and duration of use. Finally, the architecture ofthe monitor recorder 14 is open, in that other physiology sensors orcomponents can be added by virtue of the expansion port of themicrocontroller 91. Requiring those additional sensors or components todraw power from a source external to the monitor recorder 14 keeps powerconsiderations independent of the monitor recorder 14. Thus, a batteryof higher capacity could be introduced when needed to support theadditional sensors or components without effecting the monitor recorderscircuitry 90.

Second, the pair of ECG electrodes 38, 39 respectively provided on thedistal and proximal ends of the flexible circuit 32 are electricallycoupled to the set of pads 34 provided on the bottom of thenon-conductive receptacle 25 by way of their respective circuit traces33, 37. The signal ECG electrode 39 includes a protection circuit 102,which is an inline resistor that protects the patient from excessiveleakage current.

Last, in a further embodiment, the circuitry 100 of the electrode patch15 includes a cryptographic circuit 103 to authenticate an electrodepatch 15 for use with a monitor recorder 14. The cryptographic circuit103 includes a device capable of secure authentication and validation.The cryptographic device 103 ensures that only genuine, non-expired,safe, and authenticated electrode patches 15 are permitted to providemonitoring data to a monitor recorder 14. Further, the cryptographiccircuit can include readable and writeable memory for storing datareceived from the monitor recorder or external sensors, or providinginstructions to the monitor recorder and external sensors, as furtherdescribed below in detail below with reference to FIGS. 14 and 18.However, the readable and writeable memory for storing data can beprovided separately from the cryptographic circuit.

The monitor recorder 14 continuously monitors the patient's heart rateand physiology. FIG. 14 is a flow diagram showing a monitorrecorder-implemented method 140 for monitoring ECG data for use in themonitor recorder 14 of FIG. 4. Initially, upon being connected to theset of pads 34 provided with the non-conductive receptacle 25 when themonitor recorder 14 is snapped into place, the microcontroller 91executes a power up sequence (step 141) and performs self-authenticationof the electrode patch 15 (step 142). During the power up sequence, thevoltage of the battery 101 is checked, the state of the flash memory 92is confirmed, both in terms of operability check and available capacity,and microcontroller operation is diagnostically confirmed.

Self-authentication is performed between the microcontroller 91 and theelectrode patch 15 each time that the monitor recorder 14 is insertedinto an electrode patch 15 (or other accessory) to ensure patientsafety. An authenticated patch will conform to product qualitystandards, as well as applicable federal regulatory quality requirementsand international standards, such as ISO 13485, IEC 60601-2-47 and IEC60601-1. Quality assurance, through self-authentication, is crucial, aselectrode patches 15 and other accessories may be authorized, but maynot necessarily be manufactured, by the entity ultimately responsiblefor quality standards compliance. Self-authentication mitigates the riskof incorrect device output due to non-compliant accessories.

In one embodiment, the micro-controller 91 contains a private key or aprecomputed digest, of which the electrode patch 15 (or other accessory)will have a copy. To authenticate an electrode patch 15 (or otheraccessory), the micro-controller 91 will challenge the electrode patch15 (or other accessory) using a code hashed with the private key orprecomputed digest. If the electrode patch 15 (or other accessory)responds correctly, the micro-controller 91 will continue with normalprogram execution. Otherwise, the monitor recorder 14 will signal anerror condition, such as chirping the buzzer 97 to notify the patient.Failing self-authentication, other actions could also be taken.

In a further embodiment, an electrode patch 15 (or other accessory, suchas a separate physiological sensor) can be set to operate for only acertain period of time. Upon authentication, the monitor recorder 14will run with that electrode patch 15 (or other accessory) until theelectrode patch 15 (or other accessory) is depleted. If the electrodepatch 15 (or other accessory) is detected to be expired duringself-authentication, the monitor recorder 14 will fail to operate orsignal an error condition. To cause an electrode patch 15 (or otheraccessory) to expire after a certain amount of time has elapsed, themicro-controller 91 periodically writes into the read-only memory (ROM)of the cryptographic circuit 103. After the data in the ROM written bythe micro-controller 91 has reached a certain fullness, themicro-controller 91 will turn off to ensure that an expired electrodepatch 15 (or other accessory) does not create an unsafe condition, suchas an incorrect output. Still other forms of authentication and deviceexpiration are possible.

Following satisfactory completion of the power up sequence, an iterativeprocessing loop (steps 143-150) is continually executed by themicrocontroller 91. During each iteration (step 143) of the processingloop, the ECG frontend 93 (shown in FIG. 9) continually senses thecutaneous ECG electrical signals (step 144) via the ECG electrodes 38,39 and is optimized to maintain the integrity of the P-wave. A sample ofthe ECG signal is read (step 145) by the microcontroller 91 by samplingthe analog ECG signal output front end 93. FIG. 15 is a graph showing,by way of example, a typical ECG waveform 110. The x-axis representstime in approximate units of tenths of a second. The y-axis representscutaneous electrical signal strength in approximate units of millivolts.The P-wave 111 has a smooth, normally upward, that is, positive,waveform that indicates atrial depolarization. The QRS complex usuallybegins with the downward deflection of a Q wave 112, followed by alarger upward deflection of an R-wave 113, and terminated with adownward waveform of the S wave 114, collectively representative ofventricular depolarization. The T wave 115 is normally a modest upwardwaveform, representative of ventricular depolarization, while the U wave116, often not directly observable, indicates the recovery period of thePurkinje conduction fibers.

Sampling of the R-to-R interval enables heart rate informationderivation. For instance, the R-to-R interval represents the ventricularrate and rhythm, while the P-to-P interval represents the atrial rateand rhythm. Importantly, the PR interval is indicative ofatrioventricular (AV) conduction time and abnormalities in the PRinterval can reveal underlying heart disorders, thus representinganother reason why the P-wave quality achievable by the extended wearambulatory electrocardiography and physiological sensor monitordescribed herein is medically unique and important. The long-termobservation of these ECG indicia, as provided through extended wear ofthe wearable monitor 12, provides valuable insights to the patient'scardiac function and overall well-being.

Returning to the discussion with respect to FIG. 14, each sampled ECGsignal, in quantized and digitized form, is temporarily staged in buffer(step 146), pending compression preparatory to storage in the flashmemory 92 (step 147). Following compression, the compressed ECGdigitized sample is again buffered (step 148), then written to the flashmemory 92 (step 149) using the communications bus. Processing continues(step 150), so long as the monitoring recorder 14 remains connected tothe electrode patch 15 (and storage space remains available in the flashmemory 92), after which the processing loop is exited and executionterminates. Still other operations and steps are possible.

Once recorded, the ECG data can be offloaded and processed. FIG. 16 is aflow diagram showing a method 200 for offloading and converting ECG andother physiological data from an extended wear electrocardiography andphysiological sensor monitor in accordance with one embodiment. Themethod 150 can be implemented in software and execution of the softwarecan be performed on a download station 125, which could be a programmeror other device, or a computer system, including a server 122 orpersonal computer 129, such as further described supra with reference toFIG. 3, as a series of process or method modules or steps. Forconvenience, the method 200 will be described in the context of beingperformed by a personal computer 136 or other connectable computingdevice (shown in FIG. 3) as middleware that converts ECG data and otherinformation into a format suitable for use by a third-partypost-monitoring analysis program. Execution of the method 200 by acomputer system would be analogous mutatis mutandis.

Initially, the download station 125 is connected to the monitor recorder14 (step 201), such as by physically interfacing to a set of terminals128 on a paired receptacle 127 or by wireless connection, if available.The data stored on the monitor recorder 14, including ECG andphysiological monitoring data, other recorded data, and otherinformation are retrieved (step 202) over a hard link 135 using acontrol program 137 (“Ctl”) or analogous application executing on apersonal computer 136 or other connectable computing device.

The data retrieved from the monitor recorder 14 is in a proprietarystorage format and each datum of recorded ECG monitoring data, as wellas any other physiological data or other information, must be converted,so that the data can be used by a third-party post-monitoring analysisprogram. Each datum of ECG monitoring data is converted by themiddleware (steps 203-209) in an iterative processing loop. During eachiteration (step 203), the ECG datum is read (step 204) and, ifnecessary, the gain of the ECG signal is adjusted (step 205) tocompensate, for instance, for relocation or replacement of the electrodepatch 15 during the monitoring period.

In addition, depending upon the configuration of the wearable monitor12, other physiological data (or other information), including patientevents, such as a fall, peak activity level, detection of patientactivity levels and states, sedentary detection and so on, may berecorded along with the ECG monitoring data. For instance, actigraphydata may have been sampled by the actigraphy sensor 94 based on a sensedevent occurrence, such as a sudden change in orientation due to thepatient taking a fall. In response, the monitor recorder 14 will embedthe actigraphy data samples into the stream of data, including ECGmonitoring data that is recorded to the flash memory 92 by themicro-controller 91. Post-monitoring, the actigraphy data is temporallymatched to the ECG data to provide the proper physiological context tothe sensed event occurrence. As a result, the three-axis actigraphysignal is turned into an actionable event occurrence that is provided,through conversion by the middleware, to third party post-monitoringanalysis programs, along with the ECG recordings contemporaneous to theevent occurrence. Other types of processing of the other physiologicaldata (or other information) are possible.

Thus, during execution of the middleware, any other physiological data(or other information) that has been embedded into the recorded ECGmonitoring data is read (step 206) and time-correlated to the time frameof the ECG signals that occurred at the time that the otherphysiological data (or other information) was noted (step 207). Finally,the ECG datum, signal gain adjusted, if appropriate, and otherphysiological data, if applicable and as time-correlated, are stored ina format suitable to the backend software (step 208) used inpost-monitoring analysis. Processing continues (step 209) for eachremaining ECG datum, after which the processing loop is exited andexecution terminates.

Additionally, in one embodiment, the patient management program 123could manage a subscription service that authorizes a monitor recorder14 to operate for a set period of time or under pre-defined operationalparameters and privileges. FIG. 17 is a flow diagram showing a method210 for providing a self-authenticating electrocardiography monitoringcircuit in accordance with one embodiment. The method 210 can beimplemented in software and execution of the software can be performedon a download station 125, which could be a programmer or other device,or a computer system, including a server 122 or personal computer 129,such as further described supra with reference to FIG. 3, as a series ofprocess or method modules or steps. For convenience, the method 210 willbe described in the context of being performed by a download station125. Execution of the method 210 by a computer system would be analogousmutatis mutandis.

In terms of a subscription business model, devices, such as the monitorrecorder 14, could be sold at low cost, and a patient would only need topay a monitoring service provider when they want to use their device.The subscription service could be implemented by the server 122 or othercomparable computer system, which would provide a user interface topatients through which they could select and purchase desired additionalfunctionality. A patient is able to “reload” their device with more timeor pre-defined operational parameters and privileges using a challengeresponse authentication scheme through a download station 125.Initially, the patient determines what pre-defined operationalparameters or privileges he wishes to purchase (step 211), such asrunning time, number of uses, monitoring features, and so on, and thepatient's selections are provided to the server 122 using, for instance,a personal computer 129, or similar device. The download station 125connects to the monitor recorder 14 (step 212), such as by physicallyinterfacing to a set of terminals 128 on a paired receptacle 127 or bywireless connection, if available. The download station 125 communicatewith the monitor recorder 14 and requests appropriate challenges (step213), which are forwarded to the patient management program 123executing on the server 122. Upon receiving (step 214) the forwardedchallenges, the monitor recorder 14 will only unlock the requestedadditional functionality if the server 122 responds correctly (step215). Thus, the server 122 can preclude authorizing the additionalfunctionality by providing an incorrect response. Other types ofpre-defined operational parameter and privilege authorization schemesare possible.

In a further embodiment, physiological data can be collected via one ormore physiological sensors, such as a SpO₂ sensor, blood pressuresensor, temperature sensor, respiratory rate sensor, glucose sensor,airflow sensor, volumetric pressure sensing, or other types of sensor ortelemetric input sources continually or on demand as instructed by theelectrode patch. Generally, continually obtaining physiological datafrom some types of sensors, such as a high resolution temperature sensoris not optimal nor preferred due to the large amounts of processing andmemory required to obtain and store the data. However, sampling of thedata randomly or at predetermined times as instructed by the electrodepatch makes obtaining such data possible using the extended wear device,such as the electrocardiography and physiological sensor monitor. FIG.18 is a flow diagram showing, by way of example, a process 160 forobtaining physiological data from a physiological sensor. Memoryprovided on the electrode patch is programmed (step 161) to enable anddisable features, including obtaining physiological measurements via atleast one physiological sensor at different times over a period of time.In one embodiment, the authentication or crypto circuit 103 (shown inFIG. 13) on the electrode patch includes programmable read and writememory space. However, in a different embodiment, the programmable readand write memory is provided separate from the crypto circuit. In oneexample, the programmed features can include predetermined times or arequest for random times at which data is to be obtained via aphysiological monitor. Other programmable features are also possible.

Once the monitor is applied to a patient and the electrode patch isauthenticated by the monitor recorder, the electrocardiography andphysiological sensor monitor continually senses (step 162) ECG signalsupon authentication until the electrode patch is determined to beexpired or is otherwise terminated. Meanwhile, the electrode patch canrequest (step 163) readings of physiological data from one or morephysiological sensors provided as part of the circuitry of the monitorrecorder or provided on the electrode patch. Alternatively or inaddition, the physiological data can be wirelessly connected or externalto the electrocardiography and physiological sensor monitor. Whenprovided on the electrode patch, the physiological sensor cancommunicate with the micro-controller of the monitor recorder via one ormore of the electrical contacts to obtain and store the receivedphysiological data.

The request for data from the electrode patch can be provided based on aset of sampling instructions preprogrammed on the electrode patch,including instructions to request the physiological data randomly or atpredetermined times, as described above. Other types and kinds ofinstructions are possible for sampling, such as requesting a readingfrom one or more of the physiological sensors when the patient pressesthe patient tactile feedback button (shown in FIG. 4) to mark events,such as a cardiac episode, when a user is out of breath or feels hisheart racing. The electrode patch can be preprogrammed at the time ofmanufacture, or after manufacture and prior to distribution to apatient. Based on the data request, the physiological sensor for whichthe request was directed, obtains a reading of the correspondingphysiological data, which is then provided to the monitor recorder forstorage and later downloading via a download station with the ECG data.

During monitoring of the ECG signals and physiological data, adetermination is made as to whether all monitoring is complete (step164). For example, monitoring can be complete when the electrode patchexpires, such as based on an amount of data obtained or recorded, a newelectrode patch should replace the current electrode patch, or apredetermined time for monitoring has been reached, such as described incommonly-assigned U.S. patent application Ser. No. ______, entitled“Self-Expiring Electrocardiography and Physiological Sensor Monitor,”filed Dec. 3, 2018, pending, the disclosure of which is incorporated byreference. If monitoring is complete, no further ECG signals orphysiological data are recorded. However, if not complete, the ECGsignals are continually recorded (step 162), while the physiologicaldata is obtained (step 163) according to instructions from the electrodepatch.

In one embodiment, different types of physiological sensors can beincorporated into the electrode patch 15 for use with the monitorrecorder 14 as custom electrode patches. Specifically, each electrodepatch can include a different physiological sensor and the electrodepatches can be interchanged to work with the monitor recorder to obtaindifferent types of physiological data. When instructed, the electrodepatch requests a reading from the physiological sensor according toprogrammed timing. Alternatively, the physiological sensors are providedas part of the circuitry of the monitor recorder and each electrodepatch is programmed to provide sampling instructions from thephysiological sensor. For instance, some physiological data should becollected more frequently than other types of physiological data. In afurther embodiment, the electrode patch 15 can store samplinginstructions for more than one physiological sensor at a time.

In one example, a high resolution temperature sensor can be provided onthe electrode patch or as part of the circuitry of the monitor recorderto take temperature measures at a high sample rate. Instructions fromthe electrode patch, which have been preprogrammed, instruct the highresolution temperature sensor when to begin measuring temperature andwhen to stop measuring the temperature, as well as how many times thetemperature should be measured over a time period, which allows theelectrocardiography and physiological sensor monitor to obtain the dataand also continually monitor the ECG signals over time without utilizinglarge amounts of processing power and memory of the monitor. Theinstructions can also include a duration of measurement, which can bethe same or different for each obtained data measurement.

In a further embodiment, multiple patches, each programmed for adifferent physiological sensor or with different sampling rates for thesame physiological sensor can be used with the same monitor recorder.

While the invention has been particularly shown and described asreferenced to the embodiments thereof, those skilled in the art willunderstand that the foregoing and other changes in form and detail maybe made therein without departing from the spirit and scope.

What is claimed is:
 1. An extended wear electrocardiography patch,comprising: a flexible backing formed of an elongated strip ofstretchable material; an electrocardiographic electrode respectivelyaffixed to and conductively exposed on a contact surface of each end ofthe elongated strip; a flexible circuit affixed on each end to theelongated strip and comprising a pair of circuit traces each originatingwithin one of the ends of the elongated strip and electrically coupledto one of the electrocardiographic electrodes; a non-conductivereceptacle securely adhered on the one end of the elongated stripopposite the contact surface and formed to removably receive anelectrocardiography monitor operable to obtain electrocardiographicsignals through the electrocardiographic electrodes, wherein thenon-conductive receptacle comprises electrode terminals aligned toelectrically interface the pair of circuit traces to theelectrocardiography monitor; and a crypto circuit comprising memoryprogramed with a sampling rate for at least one physiological sensorprovided at least one of with the electrocardiography monitor and on theflexible backing to instruct the physiological sensor to obtain readingsof physiological data.
 2. An extended wear electrocardiography patchaccording to claim 1, further comprising: a download station configuredto retrieve the electrocardiographic signals.
 3. An extended wearelectrocardiography patch according to claim 2, further comprising:middlewear operable to convert the electrocardiographic signals into adifferent format.
 4. An extended wear electrocardiography patchaccording to claim 3, further comprising: a server to remotely interfacewith the download station and configured to retrieve the formattedelectrocardiographic signals.
 5. An extended wear electrocardiographypatch according to claim 1, wherein the physiological sensor comprisesone of a SpO₂ sensor, blood pressure sensor, temperature sensor,respiratory rate sensor, glucose sensor, airflow sensor, and volumetricpressure sensor.
 6. An extended wear electrocardiography patch accordingto claim 1, wherein the electrocardiography monitor comprises: a sealedhousing adapted to be removably secured into the non-conductive; andelectronic circuity comprised within the sealed housing, comprising: anelectrocardiographic front end circuit operable to sense theelectrocardiographic signals through the electrocardiographic electrodesprovided on the electrode patch; and flash memory to record theelectrocardiographic signals.
 7. An extended wear electrocardiographypatch according to claim 1, wherein the electronic circuitry of theelectrocardiography monitor is configured to embed the physiologicaldata into a stream of the electrocardiographic signals.
 8. An extendedwear electrocardiography patch according to claim 1, wherein thephysiological data is matched to the electrocardiographic signals.
 9. Anextended wear electrocardiography patch according to claim 1, whereinthe physiological sensor records the physiological data based on thesampling rate.
 10. An extended wear electrocardiography patch accordingto claim 1, further comprising: a battery to provide power to thephysiological sensor that is electrically interfaced with themicro-controller over the expansion bus.
 11. An extended wearelectrocardiography and physiological sensor monitor, comprising: anelectrocardiography monitor, comprising: a sealed housing; andelectronic circuitry comprised within the sealed housing, comprising: anexternally-powered micro-controller; and an electrocardiographic frontend circuit electrically interfaced to the micro-controller and operableto sense electrocardiographic signals; and an electrocardiography patch,comprising: a flexible backing formed of an elongated strip ofstretchable material; an electrocardiographic electrode affixed to andconductively exposed on a contact surface of each end of the elongatedstrip; a flexible circuit affixed on each end to the elongated strip andcomprising a pair of circuit traces each originating within one of theends of the elongated strip and electrically coupled to one of theelectrocardiographic electrodes; a non-conductive receptacle securelyadhered on the one end of the elongated strip opposite the contactsurface and formed to removably receive the electrocardiography monitor,the non-conductive receptacle comprising electrode terminals aligned toelectrically interface the pair of circuit traces to theelectrocardiography monitor; and a crypto circuit comprising memoryprogramed with a sampling rate for at least one physiological sensorprovided at least one of with the electrocardiography monitor and on theflexible backing to instruct the physiological sensor to obtain readingsof physiological data.
 12. An extended wear electrocardiography andphysiological sensor monitor according to claim 11, further comprising:a download station configured to retrieve the electrocardiographicsignals.
 13. An extended wear electrocardiography and physiologicalsensor monitor according to claim 12, further comprising: middlewearoperable to convert the electrocardiographic signals into a differentformat.
 14. An extended wear electrocardiography and physiologicalsensor monitor according to claim 13, further comprising: a server toremotely interface with the download station and configured to retrievethe formatted electrocardiographic signals.
 15. An extended wearelectrocardiography and physiological sensor monitor according to claim11, wherein each physiological sensor comprises one of a SpO₂ sensor,blood pressure sensor, temperature sensor, respiratory rate sensor,glucose sensor, airflow sensor, and volumetric pressure sensor.
 16. Anextended wear electrocardiography and physiological sensor monitoraccording to claim 11, wherein the electronic circuitry is configured toembed the physiological data into a stream of the electrocardiographicsignals.
 17. An extended wear electrocardiography and physiologicalsensor monitor according to claim 11, wherein the physiological data ismatched to the electrocardiographic signals.
 18. An extended wearelectrocardiography and physiological sensor monitor according to claim11, further comprising: at least one other electrocardiography patch toreplace the electrocardiography patch, wherein each electrocardiographypatch is specialized to provide a different sampling rate for differentphysiological data.
 19. An extended wear electrocardiography andphysiological sensor monitor according to claim 11, wherein thephysiological sensor records the physiological data based on thesampling rate.
 20. An extended wear electrocardiography andphysiological sensor monitor according to claim 11, further comprising:a battery from which the physiological sensor draws power, wherein thephysiological sensor is electrically interfaced with themicro-controller over an expansion bus; and flash memory of theelectrocardiography monitor operable through the expansion bus to storesamples of the physiological data sensed by the physiological sensor.